Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123233803 | 12323380 | 3 | F | 20160315 | 20160805 | 20160502 | 20160830 | PER | US-JNJFOC-20160415442 | JANSSEN | 29.94 | YR | A | F | Y | 78.00000 | KG | 20160830 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123233803 | 12323380 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 15KD03441;FJM87016P1;15H171P1 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 123233803 | 12323380 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 15KD03441;FJM87016P1;15H171P1 | 103772 | LYOPHILIZED POWDER | |||||||
| 123233803 | 12323380 | 3 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 123233803 | 12323380 | 4 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | TROCHE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123233803 | 12323380 | 1 | Crohn's disease |
| 123233803 | 12323380 | 2 | Crohn's disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123233803 | 12323380 | Drug hypersensitivity | |
| 123233803 | 12323380 | Exposure during pregnancy | |
| 123233803 | 12323380 | Infusion related reaction | |
| 123233803 | 12323380 | Product preparation error |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 123233803 | 12323380 | 1 | 20160331 | 20160414 | 0 | |
| 123233803 | 12323380 | 2 | 2016 | 0 |